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临床试验/NCT04508491
NCT04508491已完成不适用

The Best Treatment Strategy for the Reservation of Cognitive Function in Patients With Persisted Atrial Fibrillation

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2020年11月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
1
主要终点
Cognitive function

研究概览

简要总结

Compare the difference of cognitive function between different treatment strategy in patients with persistent atrial fibrillation

详细描述

The prevalence of atrial fibrillation (AF) had been increasing for the past decade. The increase of AF was attributed to the aging of the population and the increased awareness of the disease among people and the primary physicians. However, we have not achieved the consensus whether aggressive rhythm control or conservative rate control is better in a patient with asymptomatic persisted AF. We do prescribe anti-coagulant for stroke prevention, but which treatment strategy is best for the patients is uncertain.

The clinical trial of catheter-based ablation for rhythm control compared to traditional medication control has not shown the benefit of reducing all-cause mortality, but it did show a reduction of re-hospitalization and the recurrence of AF. On the contrary, the study in heart failure patients had shown a significant benefit applying catheter-based rhythm control strategy to reduce all-cause mortality. The different results of these two trials told us the benefit of rhythm control is not easily to be seen in a short-term, but could be seen in a long term or in high risk patients. The association between AF and cognitive impairment has also been reported in observation cohort. However, there is no sold evidence in clinical trials to show the improvement of cognitive function by treating atrial fibrillation. One study did show improvement of cognitive function with questionnaire, but the other showed new lesion detected by traditional magnetic resonance imaging (MRI) after ablation, though the lesion resolved after one year of follow-up. There is no clear answer to which treatment strategy is better for the patients' cognitive function。 Therefore, we designe a prospective, randomized, blind endpointtrial. We will enroll the patients with persisted AF, and use advanced MRI (DTI/SWI) and questionnaire to longitudinally study the cognitive function change of the patients before and after the initiation of anti-coagulant agents, before and after the catheter-based ablation, and use this as a surrogate to understand the best treatment strategy for these AF patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Those who meet the diagnosis of persistent atrial fibrillation, meet one of the following conditions:
  • •The twelve-lead electrocardiogram is used to diagnose atrial fibrillation, and to cooperate with clinical diagnosis.
  • •24 hours ECG diagnosis 100% atrial fibrillation, with clinical diagnosis.
  • •The seven-day ECG recorder diagnosed 100% atrial fibrillation.
  • •Willing to accept treatment recommended by doctors, containing anticoagulant, and cooperate with examination and treatment in the coming year.

排除标准

  • •Unwilling to sign the clinical trial consent form.
  • •Unable to complete the cognitive function questionnaire.
  • •Unable to complete brain MRI examination due to various reasons

研究组 & 干预措施

Rhythm control

Experimental

Rhythm control with medication or any procedure

干预措施: Rhythm control (Other)

Rate control

Active Comparator

Rate control with medication or any procedure

干预措施: Rate control (Other)

结局指标

主要结局

Cognitive function

时间窗: 12 months

MOCA questionnaire

次要结局

  • Quality of Life questionnaire(12 months)
  • Hospitalization for cardiovascular cause(12 months)
  • all cause mortality(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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